| Objective:The efficacy and safety evaluation of ulcerative colitis, which was sequentially treated by the QingChangHuaShi and JianPiYiQi methods of traditional Chinese medicine, and the effectiveness and intervention mechanism research of QingChangHuaShiFang decoction from the point of colon immune function of the ulcerative colitis rat, is used to provide clinical and experimental data which in order to come into being the standardized treatment of ulcerative colitis by Chinese medicine.Methods:Clinical trial according to the principle of randomization and contrast. The 71 cases diagnosed by colonoscopy with low-grade or middling ulcerative colitis were divided into TCM group (36 cases) and Mesalazine group (35 cases). TCM group patients in active stage was given QingChangHuaShiFang(p.o.) and GuanChangFang (enem.), which continue 1 week after remission and then change to FuZhengQingChangFang (p.o.).The control group was given Mesalazine (5-ASA) 4g/d, which continue 1 week after remission and then change to 1.5g/d. Follow-up 6 months after the treatment of 24 weeks. Observe the clinical efficacy,syndrome efficacy,the main symptom disappeared-rates,colonoscopy and pathological efficacy, as well as remission rate and relapse rate. Monitor the safety index. Experimental study used trinitrobenzene sulfonic acid/ethanol rat model of ulcerative colitis, and compared QingChangHuaShiFang with Balsalazide. Ig 10 days, and detect the expression levels of TNF-α,IL-8 mRNA in rat colon tissue by RT-PCR, and TLR-4,NF-κBp65,PPAR-y by Western blot.Results:Clinical trial results showed that: the clinical efficacy of TCM group was better than the Mesalazine group (P<0.05), and the markedly effective rate of syndrome efficacy (77.8%) were better than the Mesalazine group (54.3%) (P<0.05). The improvement in symptom score of TCM group was better than the Mesalazine group (P<0.05). In the three main symptoms of the UC (diarrhea,hematochezia and abdominal pain), the hematochezia and abdominal pain disappearance rate of TCM group (86.1%,75.0%) was better than the Mesalazine group (62.9%,46.2%)(P＜0.05). Colonoscopy efficacy and colon pathology efficacy of TCM group were both better than the Mesalazine group (P< 0.05). According to the changes of C-reactiveprotein levels, we had confirmed the efficacy of TCM group was better than the Mesalazine group (P＜0.01). The remission rate of TCM group (86.1%) was better than the Mesalazine group (62.9%)(P<0.05), and the relapse rate of TCM group (25.8%) was lower than the Mesalazine group (63.6%) (P< 0.01). Experimental results showed that: QingChangHuaShiFang could lower both the pathology score and the general morphology score of colon (P< 0.01). QingChangHuaShiFang could lower TNF-α,IL-8 mRNA expression in the colon of the rat (P<0.01). The reduction in the role of TNF-amRNA was better than the Balsalazide group (P<0.05). QingChangHuaShiFang could inhibit the expression of TLR-4,NF-KBp65 protein in the colon of the rat (P<0.01), and have a superior inhibitory effect than the Balsalazide group (P＜0.01). QingChangHuaShiFang could promote the expression of PPAR-y (P<0.01), but the effect was less than the Balsalazide (P<0.01).Conclusion:The results of clinical trial had shown that, QingChangHuaShi and JianPiYiQi sequential treatment was a effective treatment for the low-grade or middling ulcerative colitis. It has certain advantages in the symptom improvement,mucosal repair and reducing the relapse rate compared with mesalazine, and was safety. It was worthy to be popularized and make a further in-depth study. Preliminary studies had shown that the therapy mechanism of QingChangHuaShiFang was involved in varying degrees of intervention on the intestinal TNF-α,IL-8,TLR-4,NF-KBp65 and PPAR-y. However, the clearness of the specific pathways and key therapeutic targets of it needs a further depth study.
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